Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT00170157
Phase
PHASE2
Status
Completed

Conditions

  • Prostate Adenocarcinoma
  • Prostate Carcinoma
  • Recurrent Prostate Carcinoma
  • Stage III Prostate Cancer
  • Stage IV Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bicalutamide — DRUG
    Given orally
  • Flutamide — DRUG
    Given orally
  • Goserelin Acetate — DRUG
    Given SC
  • Ipilimumab — DRUG
    Given IV
  • Leuprolide Acetate — DRUG
    Given IM
  • Pharmacological Study — OTHER
    Correlative study

Study Details

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells. PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.

Key Dates

Start date
Jun 30, 2004
Status verified
Jan 2017
Primary completion
Apr 30, 2011
Completion
Jun 30, 2013

Study Design

Enrollment
112 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I
    Patients receive either leuprolide acetate intramuscularly (IM) or goserelin subcutaneously (SC) on days 0, 28, and 56. Patients also receive oral flutamide three times daily or oral bicalutamide once daily. Treatment with antiandrogen (AA) therapy continues for 3 months (3-4 months for patients who initiated AA therapy \<= 21 days prior to enrollment) in the absence of disease progression or unacceptable toxicity. Patients receive ipilimumab IV over 90 minutes on day 7 (within 7-28 days post-initiation of AA therapy for patients who initiated AA therapy \<= 21 days prior to enrollment) of AA therapy.
  • Active Comparator: Arm II
    Patients receive AA therapy as in arm I. Patients may crossover to arm II in the case of disease progression.

Primary Outcome Measure

Number of Participants Progression-free at 18 Months [ Time Frame: 18 months from the start of AA therapy ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-

Find similar trials in Rochester, MN

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Mayo Clinic· Rochester, MN

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